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Support operational compliance aspects of sterile fill-finish manufacturing of products including executed batch record review. Support material receipt, quality control, chain of custody, disposition, and release of materials within the Enterprise Resource Planning system.
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Conducts record review of executed batch records, QC testing data, and associated batch file documentation to ensure timely disposition of patient lots. The Sr. Quality Assurance Specialist will be responsible for supporting quality functions such as line clearance, batch record review, label issuance, raw material release and facilitating timely release of production lots.
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Supervise the QA Operations team (2nd shift) and help drive batch disposition by performing efficient reviews of records related to the manufacture and testing of iPBMCs∯*∯ Responsibilities will include on-floor support to manufacturing staff, Batch Record review, and review of Quality Records such as Deviations.
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Document test failures, place on hold and communicate with the Quality Manager for final disposition. Measure and add final batch chemicals to the test sample on the lab mill. Collect test results using a network of computers to generate a final test report for each batch.
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1 - 2 years in Quality performing batch record review and disposition of products at a regulated biotechnology or pharmaceutical company preferred. 1 - 2 years of experience performing batch record review or manufacturing using batch records at a regulated biotechnology or pharmaceutical company.
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Experience in drug product batch record review and disposition preferred. What You’ll Do Product Disposition: Reviews documents (e.g., production records, test methods, raw data, and certificates of analysis) for compliance and determines acceptability for use in GMP production activities and/or release of product for further processing and/or distribution.
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Performs batch disposition of incoming materials, semi-finished and/or finished drug product batches for Indianapolis Device Assembly and Packaging, including commercial and clinical trial materials to ensure high quality medicine (GMP Compliance) is released to market in a timely manner.
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The Senior QA Associate, Batch Release, is responsible for the management and direct oversight of processes related to the review, reconciliation and documentation of records supporting the compliance and disposition of product manufactured at Abzena's Bristol (PA) facility.
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Responsible for, but not limited to, inspecting, and receiving human and porcine tissue, batch record review, cleaning, cycle count, product/tissue quarantine, media change and disposition activities.
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Perform batch record review, and disposition related activities for Drug Substance, Drug Product, Packaging and labelling. To conduct training and coaching of the QA team members on the how to perform batch record review, documentation of findings, as well as review/evaluate adequate completion of all records requirements and via supporting documentation.
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Ensures that the QA processes including batch record review, product disposition, and quality issues resolutions are executed to maintain the flow of products and documents to meet organization objectives.
$95,000 - $136,250 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Supports disposition activities for manufactured products in support of Commercial/Clinical Product, including Master Batch Record review, Executed Batch Record review, resolution of comments/issues and Certificate of Analysis review.
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CoreWeave builds cloud solutions for compute intensive use cases - VFX and rendering, machine learning and AI, batch processing, and Pixel Streaming - that are up to 35 times faster and 80% less expensive than the large, generalized public clouds.
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Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management. Ensure manufacturing compliance with applicable procedures and batch records.
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Maintenance of an effective Quality Management System (QMS) which includes, but is not limited to, batch disposition, audits, change control, deviation, investigations, and corrective actions.
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disposition batch jobs
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